PSU — Jak2 Gene Mutation Detection Test Class II

FDA Device Classification

Classification Details

Product Code: PSU
Device Class: Class II
Regulation Number: 866.6070
Submission Type
Review Panel: PA
Medical Specialty: Medical Genetics
Implant: No

Definition

The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene. It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K172287	qiagen	ipsogen JAK2 RGQ PCR Kit	January 12, 2018
DEN160028	qiagen	ipsogen JAK2 RGQ PCR Kit	March 27, 2017